Indications For Use; Type Of User And Patient - IGEA Cliniporator EPS02 User Manual

1.3 Indications for Use

C L I N I P O R A T O R 's main indications of use are:

Electroporation of tumour cells and local electroporation of subcutaneous and cutaneous
metastasis independently from their source and from previous therapies,

Electroporation of local skin tumours relapse,

Electroporation of the human tissue,

Electroporation of tumour tissue,

Electroporation of tumour cells in bone tissue,

Electroporation of cells in culture and tissues in animals.
Beside these main indications, C L I N I P O R A T O R can be safely employed in pre-clinical or
clinical investigations and in experimental trials that foresee the application of electrical pulses
which the system is able to deliver as specified in this manual.
During electroporation of tumour tissue, it is recommended to follow the instructions indicated in
"Standard Operating Procedures for Electrochemotherapy" (see reference 8. of section 3.5).
In other cases, it is recommended to follow validated treatment procedures.

1.4 Type of User and Patient

This device shall be operated by trained medical/scientific staff instructed on electroporation
and on the correct use of the device. Please contact IGEA or its authorised distributors to
receive proper training.
There are multiple types of patients, but in any case they are always patients suffering from
pathologies which can be treated with electroporation, especially patients with tumours and/or
metastasis who can benefit from electrochemotherapy.
6
Cliniporator model EPS02 – User manual